Viewing Study NCT06612645



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06612645
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-18

Brief Title: A Phase 1 Study of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors
Sponsor: None
Organization: None

Study Overview

Official Title: Safety and Efficacy of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell CMD03 in Relapse and Refractory Pediatric Solid Tumors
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CMD03
Brief Summary: A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments
Detailed Description: Currently treatment options for pediatric solid tumors that have recurred or are unresponsive to standard treatments are limited These cancers often do not respond to other chemotherapy drugs or targeted therapies available today As a result there is currently no effective treatment for pediatric solid tumors that have recurred or are unresponsive to standard treatments

At present immunotherapy for cancer treatment is being developed This involves genetically modifying the patient39s immune cells to target specific cancer cells known as CAR T cells This approach is used to treat recurrent or unresponsive solid tumors and brain cancers that do not respond to standard treatments

The research aims to study the efficacy and safety of treating pediatric patients with recurrent or unresponsive solid tumors using a type of immunotherapy called CAR T cells These cells are engineered to express a chimeric antigen receptor that includes an interleukin-7 receptor alpha signaling domain and targets the B7-H3 antigen on tumor surfaces This research is the first of its kind conducted on Thai patients The research team expects this treatment to be highly safe and effective in controlling cancer

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None